[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"somatostatin-receptor-positive-sstr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:somatostatin-receptor-positive-sstr":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100576396","phase-3-study-to-evaluate-the-efficacy-and-safety-of-177lulu-dota-tate-in-patients-with-grade-1-and-grade-2-advanced-gep-net-100576396",false,"NCT06784752","Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET","A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 \u003C10%) Advanced GEP-NET With High Disease Burden (NETTER-3)","NETTER-3","Inclusion Criteria:\n\n* Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67 \\\u003C10%) gastroenteropancreatic neuroendocrine tumor (GEP-NET) diagnosed within 6 months prior to screening.\n* Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:\n\n  * Primary tumor or a metastatic lesion \\> 4 cm\n  * More than one tumor or metastatic lesions measuring \\> 2 cm\n  * Elevated alkaline phosphatase \\> 2.5 X upper limit of normal (ULN)\n  * Presence of bone metastasis\n  * Presence of peritoneal metastasis\n  * Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc.\n  * Symptoms due to hormone excess requiring active management\n  * Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible.\n* Participants ≥ 12 years of age.\n* RLI somatostatin receptor (SSTR) uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake assessed within 3 months prior to randomization. Any of the RLI modalities as available (some examples are listed below) can be used as per local practice:\n\n  * \\[68Ga\\]Ga-DOTA-TOC PET\u002FCT or PET\u002FMRI\n  * \\[68Ga\\]Ga-DOTA-TATE PET\u002FCT or PET\u002FMRI\n  * \\[64Cu\\]Cu-DOTA-TATE PET\u002FCT or PET\u002FMRI\n  * Somatostatin receptor scintigraphy (SRS) (planar and\u002For SPECT\u002FCT) with \\[111In\\]In-pentetreotide\n  * SRS (planar and\u002For SPECT\u002FCT) with \\[99mTc\\]Tc-octreotide.\n* Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:\n\n  * White blood cell (WBC) count ≥ 2 x 109\u002FL\n  * Platelet count ≥ 75 x 109\u002FL\n  * Hemoglobin (Hb) ≥ 8 g\u002FdL\n  * Creatinine clearance \\> 40 mL\u002Fmin calculated by the Cockcroft Gault method\n  * Total bilirubin ≤ 3 x ULN\n  * Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol\u002FL) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using Cockcroft-Gault formula. Mild decrease (grade 1) below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by Investigator.\n* ECOG performance status 0-1.\n* Presence of at least 1 measurable site of disease.\n\nExclusion Criteria:\n\n* Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.\n* Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET. If as per Investigator's opinion a participant is candidate for such therapies, such participant must not be enrolled.\n* Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of \\[177Lu\\]Lu-DOTA-TATE, or any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of \\[177Lu\\]Lu-DOTA-TATE.\n* Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.\n* Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET.\n* Any major surgery within 12 weeks prior to randomization in the study.\n* Known brain metastases.\n* Participant with known intolerance to CT scans with intravenous (i.v.) contrast due to allergic reaction or renal insufficiency. If such a participant can be imaged with MRI, then the participant would not be excluded.\n* Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients.\n* Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling\u002Fcondom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety instructions.\n\nOther protocol-defined Inclusion\u002FExclusion criteria may apply.","ALL","12 Years","100 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of the current study is to evaluate the efficacy and safety of \\[177Lu\\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \\\u003C10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden",[28,29],"Somatostatin Receptor Positive (SSTR+)","Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)",[31,32,33,34,35,36,37,38,39,15,40,41,42,43,44,45,46,47,48,49,50,51,52],"SSTR+","GEP-NET","Ki-67 \u003C10%","AAA601","[177Lu]Lu-DOTA-TATE","newly diagnosed","well differentiated","advanced GEP-NETs","high disease burden","Grade 1","Grade 2","Tumor-targeted radioligand therapy","RLT","octreotide LAR","Gastroenteropancreatice Neuroendocrine Tumor","PFS","Quality of life (QOL)\u002FPRO","QoL","neuroendocrine tumor(s)","Lutathera","Lutetium dotatate","Lutetium oxodotreotide","RECRUITING","2026-09-10",{"date":56,"type":57},"2026-09-11","ACTUAL",{"date":59,"type":57},"2025-05-30",{"date":61,"type":22},"2034-01-23",{"name":63,"class":64},"Novartis Pharmaceuticals","INDUSTRY",67]